medical Class II Updated 2021-09-01

Philips North America Llc recalls Achieva 3.0T-Magnetic Resonance Medical Electrical Systems i

Recalled Product

Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781277 (OUS)

Hazard / Issue

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: S/N and UDI: N/A
View official government recall

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